Director, Global Regulatory Affairs & Intelligence
Benefits:
Generous paid-time off
Stock incentive plans
Medical/Dental/Vision, Disability + Life Insurance
One Medical membership
Parental Leave
Education Requirements:
Bachelor's degree in a STEM field (Engineering, Life Sciences, or related discipline)
Advanced degree preferred
Experience Requirements:
10+ years of progressive regulatory affairs experience with Class II medical devices and SaMD
Deep expertise in global regulatory frameworks (FDA 510(k)/De Novo, EU MDR, ISO 13485)
Proven track record managing regulatory authority interactions and pre-submission meetings
Experience leading small regulatory teams in fast-paced environments
Experience with AI/ML-enabled medical devices and algorithm change protocols
Other Requirements:
Proficiency with regulatory information management and quality management systems
Ability to translate emerging requirements into actionable business recommendations
RAC certification preferred
Responsibilities:
Own and drive end-to-end regulatory strategy from concept through commercialization
Lead and execute regulatory submissions (FDA, CE Mark, Health Canada, PMDA)
Serve as the regulatory lead for the company, managing all interactions with authorities
Partner with cross-functional teams to define and proactively embed regulatory requirements into workflows
Establish and lead a proactive regulatory intelligence program to monitor global requirements
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